- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661592
NCP 2.0 Repeat Study
Assessing Repeatability of the NeuroCatch Platform 2.0 Stimulus Sequences
The NeuroCatch Platform™ version 2.0 (NCP2.0), an investigational medical device system developed by NeuroCatch Inc., consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP; brain response to a stimulus) information.
The purpose of the study is to understand how reliable and repeatable the ERP metrics elicited by the NCP platform are within participants over multiple sessions.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Surrey, British Columbia, Canada, V3V 0C6
- HealthTech Connex Inc. Centre for Neurology Studies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any sex, at least 19 years of age or older
- Able to understand the informed consent form, study procedures and willing to participate in study
- Able to remain seated and focused for 7 minutes
- In good health with no history of clinically relevant neurological illness or injury in the last 5 years
Exclusion Criteria:
- Requires the use of hearing aids or a cochlear implant, diagnosed with tinnitus that is currently active, or has temporary damage to earing (e.g. punctured ear drum). Or unable to detect a 740Hz tone played at 85dB in both ears.
- Implanted pacemaker or implanted electrical stimulators
- Metal or plastic implants in the skull, excluding dental/facial implants
- Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device while enrolled in this study
- Not proficient in English language
- Diagnosed epilepsy or history of seizures
- If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
- Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control
Neurologically healthy individuals will be recruited for the longitudinal study
|
To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the NeuroCatch™ Platform version 2.0, an investigational medical device.
Each sequence consists of tones and word pairs to elicit the various components of interest.
Version 2.0 of the NeuroCatch™ Platform consists of a computerized acquisition software which presents the stimulus, acquires the data and presents the amplitude and latency values of the ERP components (N100, N400, P300)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Amplitude (response size) will be measured in microvolts.
The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC).
Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
|
Baseline, +1 Week, +2 Weeks
|
Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Amplitude (response size) will be measured in microvolts.
The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
|
Baseline, +1 Week, +2 Weeks
|
Change in Latency of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Latency (response speed) will be measured in milliseconds.
The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC).
Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
|
Baseline, +1 Week, +2 Weeks
|
Change in Latency of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Latency (response speed) will be measured in milliseconds.
The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
|
Baseline, +1 Week, +2 Weeks
|
Change in amplitudes of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Amplitude (response size) will be measured in microvolts.
The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC).
Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
|
Baseline, +1 Week, +2 Weeks
|
Change in amplitudes of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Amplitude (response size) will be measured in microvolts.
The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
|
Baseline, +1 Week, +2 Weeks
|
Change in Latency of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Latency (response speed) will be measured in milliseconds.
The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC).
Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
|
Baseline, +1 Week, +2 Weeks
|
Change in Latency of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Latency (response speed) will be measured in milliseconds.
The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
|
Baseline, +1 Week, +2 Weeks
|
Change in amplitudes of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Amplitude (response size) will be measured in microvolts.
The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC).
Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
|
Baseline, +1 Week, +2 Weeks
|
Change in amplitudes of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Amplitude (response size) will be measured in microvolts.
The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
|
Baseline, +1 Week, +2 Weeks
|
Change in Latency of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Latency (response speed) will be measured in milliseconds.
The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC).
Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
|
Baseline, +1 Week, +2 Weeks
|
Change in Latency of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time Frame: Baseline, +1 Week, +2 Weeks
|
Latency (response speed) will be measured in milliseconds.
The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
|
Baseline, +1 Week, +2 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collection and evaluation of adverse events and adverse device effects
Time Frame: At time of event
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Evaluation of safety and tolerability of the NeuroCatch™ Platform device
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At time of event
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Change in hours of sleep of the day of scan
Time Frame: Baseline, +1 Week, +2 Weeks
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Secondary statistical analyses will explore the correlation between hours of sleep on the day of scan with changes in ERP measures (primary outcomes) across the sample
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Baseline, +1 Week, +2 Weeks
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Change in perceived mood on the day of scan
Time Frame: Baseline, +1 Week, +2 Weeks
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Secondary statistical analyses will explore the correlation between perceived mood (ranked on a scale of 0-100) on the day of scan with changes in ERP measures (primary outcomes) across the sample
|
Baseline, +1 Week, +2 Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Venter, MD, HealthTech Connex Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NCI_NCClin_004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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